News
Organon unveils study of medical device for postpartum haemorrhage control
Postpartum haemorrhage is a severe vaginal bleeding that can occur within a day of giving birth or up to 12 weeks postpartum

The women’s health company Organon has announced the first observational study of its medical device for postpartum haemorrhage control.
The company has said that the Obstetrics & Gynecology journal published the results of the RUBY study which reached its primary effectiveness outcome of treating abnormal postpartum uterine bleeding and postpartum haemorrhage (PPH) with Organon’s JADA System.
JADA is an intrauterine vacuum-induced haemorrhage control device intended to provide control and treatment of abnormal PPH, a severe vaginal bleeding after childbirth that can occur within a day of giving birth or up to 12 weeks postpartum.
“PPH is a potentially life-threatening obstetric emergency that can occur after childbirth and requires timely medical intervention,” explained lead author Dena Goffman, a maternal-foetal medicine subspecialist, and professor and vice chair for quality and patient safety in the Department of Obstetrics and Gynecology at Columbia University Irving Medical Center in New York.
“Appropriate management of abnormal postpartum uterine bleeding is critical to minimise the potential clinical consequences of PPH and its associated severe maternal morbidities, such as the need for blood transfusions, ICU admission or hysterectomy.
“The new study, which included a larger population than the pivotal trial, showed how the device is being used outside of a controlled clinical trial environment.
“The results indicate that the intrauterine vacuum-induced haemorrhage control device is an important tool for PPH management.”
The study assessed records of 800 patients across 16 US hospitals from October 2020 through March 2022 and evaluated JADA treatment of abnormal postpartum uterine bleeding and PPH in “real-world” settings.
Treatment success was defined as bleeding control after insertion with no treatment escalation or bleeding recurrence.
According to Organon, JADA achieved treatment success in both the vaginal (92.5 per cent) and cesarean birth (83.7 per cent) groups, regardless of the cause of the abnormal PPH.
When reviewing patient cases that received standard PPH interventions plus the JADA System, lower blood loss prior to device insertion was associated with lower severe maternal morbidity.
Patricia Carney, Organon director of medical affairs, said: “Severe maternal morbidity rates in the US are rising, and PPH is recognised as a major cause of some of these morbidities.
“While severe maternal morbidities occurred even at lower levels of blood loss in this study, higher rates of morbidity were associated with higher levels of blood loss prior to JADA treatment in conjunction with other interventions that may have been used.
“These data shed light on the importance of appropriate control of blood loss, and it’s encouraging that the RUBY study reinforced the JADA pivotal study results in a real-world setting.”
Organon said adverse events in RUBY were consistent with the study PEARLE and what would be expected when managing an obstetric emergency.
Three serious adverse device events were deemed possibly related to the device or procedure, all of which resolved with treatment, the company added.
Opinion
We built Ema like a nurse: Here’s why that matters

By Claire Pettengill, science intern and Jade Anstine, clinical AI intern, Ema EQ
Every year, Gallup asks Americans which professions they trust most. Every year, nurses win. Not doctors. Not scientists. Nurses. And if you spend any time thinking about why, the answer is not hard to find.
Medicine runs on the nurse noticing first. In other words, the diagnosis follows the nurse sounding the alarm. They ask questions that feel human, not procedural. They explain what is happening in language you can understand.
And, critically, they know when something is beyond their scope and get you to the right person without making you feel like a burden for needing more.
That is the model we built Ema on.
When we set out to build an AI companion for women’s health, we could have just built something that answers questions efficiently. Pattern matching. Fast retrieval. Clinically accurate outputs.
Those things matter, and Ema does all of them. But accuracy alone does not build trust, and trust is the entire game in healthcare.
A woman asking about her postpartum recovery, her fertility, or her breastfeeding supply is not looking for a search engine. She is looking for someone who will take her seriously.
Women’s concerns don’t just need to be ‘validated’; they also need to be believed. Dismiss a woman’s pain as anxiety once, and you’ve taught her to doubt her own body.
The nursing model of care is built on exactly that premise. It is care that is shaped by her story. It asks about context and symptoms.
It treats the person as a whole, and it recognises that the right answer is sometimes a referral, not a response.
We trained Ema to escalate. That may sound like a small thing, but in AI, it is a deliberate design choice.
Most AI systems are optimised to answer and maintain engagement. Ema is optimised to help, and sometimes helping means saying “you need to speak to a clinician” and making that path easy.
This matters especially in women’s health, where the clinical trust gap is well-documented.
In a 2022 nationally representative survey of over 5,000 women, nearly 1 in 3 reported that their doctor had dismissed their concerns, and 15 per cent said a provider simply didn’t believe them.
Women are more likely to have their symptoms dismissed, their concerns minimised, and their pain undertreated. Among women under 35, nearly half reported at least one of these experiences.
They have had to learn how to advocate within systems designed for efficiency, built on men’s health.
With Ema, every conversation is an opportunity to make a woman feel heard, informed, and directed to the right level of care, neither over-triaged nor undertreated.
The goal is not to replace clinicians. It is to create a trustworthy first point of support that listens carefully, explains clearly, recognises limits, and helps women move toward appropriate care.
The nurses who top those Gallup rankings every year earn that trust through consistency. They show up, listen, follow through, and know their limits.
Ema is simply that trust, built into technology. That is the standard we hold Ema to: a trustworthy presence that knows when to answer and when to hand off.
Medicine spent a long time teaching women not to expect to be believed. Ema is built by the people who never stopped listening.
Bios
Claire Pettengill is a psychiatric nurse and DNP-PMHNP candidate at Columbia University School of Nursing, specialising in women’s mental health across the lifespan and algorithmic justice – ensuring the AI tools shaping women’s care are built to actually listen. She joined Ema EQ as a science intern focusing on clinical safety standards for evaluating AI in women’s health.
Jade Anstine is a senior nursing student at Gustavus Adolphus College looking to bridge the gap between frontline medicine and digital health innovation. He joined Ema EQ as a Clinical AI Intern to assess the Ema AI model across different clinical populations, specifically pediatrics and LGBTQ+.
Cancer
Thousands of women could avoid painful cancer exam with new AI blood test

An AI blood test being trialled by the NHS could spare thousands of women a painful examination for suspected womb cancer.
Around 90,000 postmenopausal women in England are referred by their GP each year to be investigated for possible womb cancer because of heavy bleeding.
Around 10,000 women a year in England are diagnosed with the disease, also known as uterine or endometrial cancer, and 2,700 die from it.
The PinPoint blood test could save one in five of those women, around 18,000 a year, from undergoing a transvaginal ultrasound scan.
Dr Jacinta Walsh, a GP at King’s Medical Practice in Normanton, West Yorkshire, said: “It often takes up to six visits to a GP before we’re able to rule out cancer.
“PinPoint will help shortcut that process to deliver peace of mind earlier and free up our capacity to see other patients.”
The procedure involves inserting an ultrasound probe into the vagina to measure the thickness of the womb lining. Many women find it uncomfortable or painful.
Although 20 per cent of women referred turn out not to have the disease, all currently undergo a pelvic examination involving an ultrasound scan.
If doctors still suspect cancer, women may then have a tissue sample taken during a biopsy and a hysteroscopy, an examination of the inside of the womb.
Several NHS hospitals are introducing the blood test after a trial involving 16,481 patients referred by GPs at 170 practices in Yorkshire for nine different forms of cancer.
All the patients had the test, including 3,313 women referred because their bleeding raised concerns that they might have womb cancer.
The results showed that the test was 99 per cent accurate in detecting the gynaecological cancers found among the 3,313 women and ruling out their presence.
This was a higher success rate than conventional testing. About one in 10 of the 90,000 women referred because of heavy bleeding turned out to have cancer.
The findings have prompted Mid Yorkshire NHS Teaching Trust to plan to use the test for six types of gynaecological or upper gastrointestinal cancer.
Leeds Teaching Hospitals NHS Trust plans to use it for gynaecological cancer.
The test was developed by Leeds-based PinPoint Data Science, which specialises in the statistical analysis of medical data.
It uses machine learning to assess whether someone is at low, elevated or high risk of cancer by analysing 30 blood markers.
Professor Sean Duffy, the company’s chief medical officer and a former NHS England national clinical director for cancer, said the test’s 99 per cent accuracy for womb cancer “is remarkable by any clinical standards”.
He added: “But equally, its value lies in safely ruling out very low-risk women. This has the potential to spare thousands of patients from painful invasive procedures they do not need.”
Brent Kilmurray, chief executive of the Mid Yorkshire trust, said there was an “especially compelling” case for hospitals to use the PinPoint test to detect gynaecological cancers.
Tracy Jackson, a consultant gynaecologist and cancer unit lead at the Leeds trust, said women referred by GPs currently undergo a transvaginal scan and, if needed, a hysteroscopy.
She said: “But the reality is that most women we see do not have cancer and we are acutely aware that the investigations can be uncomfortable and, for some, distressing.
“The PinPoint test gives us a way to triage more intelligently. If we can confidently rule out low-risk women in primary care, we reduce unnecessary invasive procedures and shorten our waiting lists.
“That means the women who do have cancer can be seen, diagnosed and treated earlier, which is exactly where our focus should be.”
Cancer Research UK said the PinPoint test appeared “promising”.
Samantha Harrison, a spokesperson for the charity, said: “Spotting cancer early saves lives, but right now patients are not being diagnosed quickly enough.
“This test could help to rule out endometrial cancer in some women, through a simple blood test, without the need for further testing.
“More research is needed to understand the benefits for patients and the NHS, but the results of this study are promising.”
News
Non-hormonal therapy shows menopause promise

A non-hormonal therapy restored vaginal tissue in an animal study, suggesting a possible new treatment for menopause-related GSM.
Genitourinary syndrome of menopause, or GSM, is a chronic condition caused by falling oestrogen levels.
It affects the vulva, vagina and urinary tract, causing symptoms including vaginal dryness, painful sex and recurring vaginal or urinary tract infections.
Steve Nordeen, the study’s senior author and professor emeritus in the department of pathology at the CU Anschutz School of Medicine, said: “For too many women, the current options are either products that only provide temporary relief or hormone-based treatments they may not feel comfortable using.
“Our goal was to develop a therapy that addresses the underlying cause of the vaginal changes that follow menopause, not just the symptoms, without relying on steroid hormones.
“While more research is needed, these findings suggest we may have a promising new approach.”
Researchers at the University of Colorado Anschutz developed the treatment to restore oestrogen signalling only within vaginal tissue, without exposing the rest of the body to the hormone.
In a preclinical animal study, the therapy restored vaginal tissue structure and function lost through oestrogen deficiency.
The results suggest it could address the underlying cause of GSM rather than offer only temporary relief from symptoms.
An estimated 50 to 70 per cent of women experiencing natural or medically induced menopause develop one or more symptoms of GSM.
Women may have to choose between living with painful symptoms, using over-the-counter products with limited effectiveness or taking hormone-based treatments that replace oestrogen.
Some women cannot or choose not to use hormone therapy because of concerns about potential risks. This is particularly relevant to those with a history of breast cancer or an increased risk of hormone-sensitive cancers.
The researchers synthesised a novel non-steroidal oestrogen-signalling molecule called 3-fluoro 6,4′-dihydroxyflavone, or 3F.
Delivered as a vaginal suppository, the therapy regenerated the vaginal epithelium in a preclinical model of menopause. The epithelium is the layer of cells lining the vagina.
Researchers found no evidence of systemic oestrogenic activity, meaning the treatment did not appear to trigger oestrogen responses elsewhere in the body.
The team is seeking support to move the treatment into human clinical trials.
Nordeen said: “Our findings suggest the prospect of a safer and more effective therapy is within reach.
“The next step is securing the support needed to move this therapy into human clinical trials so we can determine whether it offers women a new treatment option.”
The researchers said the therapy could provide a new option for millions of women with GSM if future clinical trials confirm the findings.
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